Cleared Traditional

K934728 - SUNSOR ULTRAVIOLET METER

K934728 is an FDA 510(k) clearance for SUNSOR ULTRAVIOLET METER, manufactured by Sunsor, Inc.. The device is a Class 2 Dental device with product code EAQ cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K934728 · Sunsor, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
302d
Days
Class 2
Risk

K934728 is an FDA 510(k) clearance for the SUNSOR ULTRAVIOLET METER. Classified as Detector, Ultraviolet (product code EAQ), Class II - Special Controls.

Submitted by Sunsor, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on July 28, 1994 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6350 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunsor, Inc. devices

FDA 510(k) Submission Details - K934728

510(k) Number K934728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date July 28, 1994
Days to Decision 302 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 127d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAQ Device Classification - Class 2, Special Controls

Product Code EAQ Detector, Ultraviolet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.